At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 23 enrolled
Drug / intervention
Alectinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Three-Period, Fixed Sequence Study to Investigate the Effect of Multiple Oral Doses of Posaconazole, a Potent Cytochrome P450 3A Inhibitor, on the Single Dose Pharmacokinetics of RO5424802 in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Alectinib and Posaconazole for Healthy Volunteer. Completed, enrolled 23 participants across 1 site.
Detailed Summary
This open-label study will investigate whether multiple oral doses of posaconazole affect the single dose pharmacokinetics of alectinib in healthy volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteer
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartDec 2013
Primary CompletionMar 2014
TodayJul 2026
First PostedNov 14, 2013
Enrollment StartDec 1, 2013
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.6 years ago
Interventions
Alectinibdrug
Alectinib will be administered as a single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants).
Posaconazoledrug
Posaconazole will be administered as a 400-mg BID oral dose after a high-fat meal on Days 8 to 14 (Period 2) and Days 15 to 18 or 21 (Period 3).